๐ณ๐ฌ% ๐ผ๐ณ ๐๐น๐ถ๐ป๐ถ๐ฐ๐ฎ๐น ๐ง๐ฟ๐ถ๐ฎ๐น๐ ๐๐ฎ๐ถ๐น ๐๐๐ฒ ๐๐ผ ๐๐ฒ๐น๐ฎ๐๐: ๐๐ผ๐ ๐๐ผ ๐๐ถ๐ ๐ฌ๐ผ๐๐ฟ ๐๐ผ๐ด๐ถ๐๐๐ถ๐ฐ๐ ๐๐ผ ๐๐๐ผ๐ถ๐ฑ ๐๐ผ๐๐๐น๐ ๐ ๐ถ๐๐๐ฎ๐ธ๐ฒ๐ https://lnkd.in/e97BFMec #compliance #quality #regulatory #clinical #pharmaceutical #biotechnology #consulting #fda Get in touch ๐ย https://lnkd.in/eaqqYzQk
BIOBOSTON CONSULTING
Business Consulting and Services
Boston, Massachusetts 7,053 followers
Helping the Life Sciences Industry from Pre-Clinical to Commercial. ๐กGet Started with the link below ๐
About us
BioBoston Consulting, headquartered in Boston, is a Life Science consulting firm that provides strategic regulatory, quality, clinical and organizational support to pharmaceutical, biotechnology, and medical device organizations from the early stages of product development through to commercialization.
- Website
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https://www.biobostonconsulting.com
External link for BIOBOSTON CONSULTING
- Industry
- Business Consulting and Services
- Company size
- 11-50 employees
- Headquarters
- Boston, Massachusetts
- Type
- Privately Held
- Specialties
- QMS Implementation, Quality Assurance & Regulatory Compliance, Inspection Readiness, Gap Assessment & Remediation, Internal Audits, Supplier Audits, Supplier Management, Qualification & Validation, Regulatory Affairs, Clinical Affairs, Technology Transfer, Risk Management, Project Management, Training, CSV, Clinical Trials, Regulatory Submissions, IND/IDE/NDA/BLA/PMA, IVDR, MDSAP, FDA Inspection Readiness, CMO and CRO Management, and Mock FDA Inspection
Locations
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Primary
75 State St
100
Boston, Massachusetts 02109, US
Employees at BIOBOSTON CONSULTING
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Abhay Gupta
Freelance Consultant (Pharmaceutical & Regulatory Sciences)
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Beatriz Rodriguez Vera
Industrial Microbiology | Quality Assurance | R&D | Consulting | Women Mentoring | GxP | ABIHPEC
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Manjusha Kadiyala
Pharmaceutical Consultant
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Angel Estrada, Ph.D. MSQA
Global Expert in Life Sciences Quality & Regulatory
Updates
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๐๐๐ฎ๐น ๐ฎ๐ฐ๐๐ถ๐ผ๐ป ๐ฎ๐ป๐๐ถ๐ฏ๐ถ๐ผ๐๐ถ๐ฐ ๐ฐ๐ผ๐๐น๐ฑ ๐บ๐ฎ๐ธ๐ฒ ๐ฏ๐ฎ๐ฐ๐๐ฒ๐ฟ๐ถ๐ฎ๐น ๐ฟ๐ฒ๐๐ถ๐๐๐ฎ๐ป๐ฐ๐ฒ ๐ป๐ฒ๐ฎ๐ฟ๐น๐ ๐ถ๐บ๐ฝ๐ผ๐๐๐ถ๐ฏ๐น๐ฒ A new antibiotic that works by disrupting two different cellular targets would make it 100 million times more difficult for bacteria to evolve resistance, according to new research from the University of Illinois Chicago. Researchers from UIC, in a new study published in Nature Chemical Biology, explored how synthetic antibiotics called macrolones combat bacterial infections by disrupting protein production or corrupting DNA structure. ๐ฌ Macrolones uniquely combine the mechanisms of macrolides and fluoroquinolones, making bacterial resistance nearly impossible due to the dual attack. ๐ Polikanov's team discovered that macrolones bind more effectively to ribosomes, even in resistant strains, without triggering resistance genes. The most promising macrolone effectively targets both ribosomes and DNA gyrase at low doses, complicating bacterial defense mechanisms. โก The interdisciplinary collaboration at UIC underscores the potential of optimizing macrolones for dual-target efficacy in future antibiotic development. Get in touch ๐ย https://lnkd.in/eaqqYzQk
Top Pharmaceutical Consulting Firm in Boston | BioBoston Consulting
biobostonconsulting.com
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๐จ๐ป๐น๐ผ๐ฐ๐ธ๐ถ๐ป๐ด ๐ฆ๐๐ฐ๐ฐ๐ฒ๐๐: ๐ณ ๐๐น๐ฎ๐ฟ๐บ๐ถ๐ป๐ด ๐ฆ๐๐ฎ๐๐ถ๐๐๐ถ๐ฐ๐ ๐ผ๐ป ๐๐น๐ถ๐ป๐ถ๐ฐ๐ฎ๐น ๐๐ฒ๐๐ฒ๐น๐ผ๐ฝ๐บ๐ฒ๐ป๐ ๐ฃ๐น๐ฎ๐ป๐ ๐ฌ๐ผ๐ ๐๐ฎ๐ป'๐ ๐๐ด๐ป๐ผ๐ฟ๐ฒ https://lnkd.in/eQEiPwze #compliance #quality #regulatory #clinical #pharmaceutical #biotechnology #consulting #fda Free consultation ๐https://lnkd.in/e52sdG3P
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๐จ๐ป๐น๐ผ๐ฐ๐ธ๐ถ๐ป๐ด ๐ฆ๐๐ฐ๐ฐ๐ฒ๐๐: ๐ณ ๐๐น๐ฎ๐ฟ๐บ๐ถ๐ป๐ด ๐ฆ๐๐ฎ๐๐ถ๐๐๐ถ๐ฐ๐ ๐ผ๐ป ๐๐น๐ถ๐ป๐ถ๐ฐ๐ฎ๐น ๐๐ฒ๐๐ฒ๐น๐ผ๐ฝ๐บ๐ฒ๐ป๐ ๐ฃ๐น๐ฎ๐ป๐ ๐ฌ๐ผ๐ ๐๐ฎ๐ป'๐ ๐๐ด๐ป๐ผ๐ฟ๐ฒ https://lnkd.in/eQEiPwze #compliance #quality #regulatory #clinical #pharmaceutical #biotechnology #consulting #fda Free consultation ๐https://lnkd.in/e52sdG3P
Unlocking Success: 7 Alarming Statistics on Clinical Development Plans You Can't Ignore
BIOBOSTON CONSULTING on LinkedIn
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๐๐๐ ๐ฑ๐ฟ๐ฎ๐ณ๐ ๐ด๐๐ถ๐ฑ๐ฎ๐ป๐ฐ๐ฒ ๐ฎ๐ฑ๐ฑ๐ฟ๐ฒ๐๐๐ฒ๐ ๐บ๐ฎ๐ป๐๐ณ๐ฎ๐ฐ๐๐๐ฟ๐ถ๐ป๐ด ๐ฐ๐ต๐ฎ๐ป๐ด๐ฒ๐ The FDA's draft guidance issued on Monday provides detailed instructions on how manufacturers should report postapproval manufacturing changes for licensed biosimilar and interchangeable products. This guidance is presented in a question-and-answer format and addresses common queries related to postapproval changes, fulfilling a commitment made in the 2022 reauthorization of the Biosimilar User Fee Act (BsUFA III) for fiscal years 2023 through 2027. ๐๐ฎ๐๐ฒ๐ด๐ผ๐ฟ๐ถ๐ฒ๐ ๐ผ๐ณ ๐ฃ๐ผ๐๐๐ฎ๐ฝ๐ฝ๐ฟ๐ผ๐๐ฎ๐น ๐๐ต๐ฎ๐ป๐ด๐ฒ๐: ๐น Major Changes: Require the filing of a Prior Approval Supplement (PAS). ๐น Moderate Changes: Require the filing of a Changes Being Effected-30 days supplement (CBE-30). ๐น Minor Changes: Require only the filing of an annual report. ๐๐ผ๐บ๐ฝ๐ฎ๐ฟ๐ฎ๐ฏ๐ถ๐น๐ถ๐๐ ๐ฆ๐๐๐ฑ๐ถ๐ฒ๐: Manufacturers should use well-qualified, in-house reference materials for comparability studies to evaluate the impact of manufacturing changes on biosimilar or interchangeable biosimilar products. ๐๐ป๐๐ฟ๐ผ๐ฑ๐๐ฐ๐๐ถ๐ผ๐ป ๐ถ๐ป๐๐ผ ๐ ๐๐น๐๐ถ๐ฝ๐ฟ๐ผ๐ฑ๐๐ฐ๐ ๐๐ฎ๐ฐ๐ถ๐น๐ถ๐๐ถ๐ฒ๐: Risks associated with introducing a licensed biosimilar or interchangeable biosimilar into a multiproduct manufacturing area or contract manufacturing facility must be assessed. Control measures should ensure the product meets its quality characteristics, including purity, with identity testing as a key tool. ๐๐ฑ๐ต๐ฒ๐ฟ๐ฒ๐ป๐ฐ๐ฒ ๐๐ผ ๐๐๐ ๐๐๐ถ๐ฑ๐ฎ๐ป๐ฐ๐ฒ: Applicants are advised to follow the International Council for Harmonizationโs (ICH) Q5E guidance on biotech comparability, issued in June 2005, when making manufacturing changes to licensed biosimilar or interchangeable biosimilar products. The draft guidance aims to clarify and streamline the process for reporting manufacturing changes for biosimilar and interchangeable biosimilar products, ensuring that quality and safety are maintained while accommodating advancements and changes in manufacturing practices. By following these guidelines, manufacturers can better navigate regulatory requirements and maintain compliance with FDA standards. Free consultation ๐https://lnkd.in/e52sdG3P
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๐ณ๐ฌ% ๐ผ๐ณ ๐๐น๐ถ๐ป๐ถ๐ฐ๐ฎ๐น ๐ง๐ฟ๐ถ๐ฎ๐น๐ ๐๐ฎ๐ฐ๐ฒ ๐๐ฎ๐๐ฎ ๐๐ฟ๐ฒ๐ฎ๐ฐ๐ต๐ฒ๐: ๐ช๐ต๐ ๐ฌ๐ผ๐๐ฟ ๐ฅ๐ฒ๐๐ฒ๐ฎ๐ฟ๐ฐ๐ต ๐๐ผ๐๐น๐ฑ ๐๐ฒ ๐ฎ๐ ๐ฅ๐ถ๐๐ธ https://lnkd.in/esrgS-Zy #compliance #quality #regulatory #clinical #pharmaceutical #biotechnology #consulting #fda Get in touch ๐ https://lnkd.in/eaqqYzQk
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๐ณ๐ฌ% ๐ผ๐ณ ๐๐น๐ถ๐ป๐ถ๐ฐ๐ฎ๐น ๐ง๐ฟ๐ถ๐ฎ๐น๐ ๐๐ฎ๐ฐ๐ฒ ๐๐ฎ๐๐ฎ ๐๐ฟ๐ฒ๐ฎ๐ฐ๐ต๐ฒ๐: ๐ช๐ต๐ ๐ฌ๐ผ๐๐ฟ ๐ฅ๐ฒ๐๐ฒ๐ฎ๐ฟ๐ฐ๐ต ๐๐ผ๐๐น๐ฑ ๐๐ฒ ๐ฎ๐ ๐ฅ๐ถ๐๐ธ https://lnkd.in/esrgS-Zy #compliance #quality #regulatory #clinical #pharmaceutical #biotechnology #consulting #fda Get in touch ๐ย https://lnkd.in/eaqqYzQk
70% of Clinical Trials Face Data Breaches: Why Your Research Could Be at Risk
BIOBOSTON CONSULTING on LinkedIn
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